Sciatic Nerve Block, Adductor Canal Block, or IPACK Block
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IPACK block
adductor canal block
sciatic nerve block
Sponsored by
About this trial
This is an interventional supportive care trial for Post Operative Pain focused on measuring IPACK , Sciatic nerve block , adductor canal block
Eligibility Criteria
Inclusion Criteria: ASA I or II physical status undergoing elective major knee surgery Exclusion Criteria: refusal of the patients to give informed consent, preexisting coagulation disorders, known allergies to aminoamide local anesthetics, local infection at the site of the block, morbid obesity, hepatic and renal diseases patients with psychological disorders
Sites / Locations
- Faculty of Medicine, University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
IPACK block
sciatic nerve block
adductor canal block
Arm Description
Outcomes
Primary Outcome Measures
change of visual analogue scale
a scale from 0 to 10 as the patient will be asked to express his pain on the scale higher scale means a worse outcome
Secondary Outcome Measures
time for fisrt analgesic request
when VAS is 4 or more longer time means a better outcome
total morphine consumption
intraoperative and post operative higher consumption means a worse outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05684107
Brief Title
Sciatic Nerve Block, Adductor Canal Block, or IPACK Block
Official Title
Femoral Nerve Block Combined With Sciatic Nerve Block Adductor Canal Block Or (Interspace Between The Popliteal Artery And The Capsule Of The Posterior Knee) IPACK Block For Postoperative Analgesia After Major Knee Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
IPACK , Sciatic nerve block , adductor canal block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPACK block
Arm Type
Active Comparator
Arm Title
sciatic nerve block
Arm Type
Active Comparator
Arm Title
adductor canal block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
IPACK block
Intervention Description
the probe is applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe is slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. a spinal needle 22G x 3.5 inches is advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reached the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
Intervention Type
Procedure
Intervention Name(s)
adductor canal block
Intervention Description
the transducer is placed anteromedially, approximately at the junction between the middle and distal third of the thigh or somewhat lower.
The saphenous nerve block should be performed at the most distal level where the artery still lies immediately deep to the sartorius muscle, thus minimizing the amount of motor nerve block of the vastus medialis; an adductor canal nerve block is typically performed more proximally, around the mid-thigh level. The needle is inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery. Once the needle tip is visualized anterior to the artery and after careful aspiration, 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
Intervention Type
Procedure
Intervention Name(s)
sciatic nerve block
Intervention Description
patient in a supine position with the hip and knee on the operated side flexed and the leg externally rotated at approximately 45 degrees. The ultrasound transducer is first positioned perpendicular to the skin approximately 8 cm distal to the inguinal crease. The location is then scanned by sliding and tilting the transducer until a clear transverse image of the hyperechoic sciatic nerve located posterior and medial to the lesser trochanter is obtained. a spinal needle 22G x 3.5 inches is advanced parallel and in line with the ultrasound transducer while the sciatic nerve is kept in the middle of the screen. The needle is advanced slowly under real-time ultrasound guidance until it is near the nerve then negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
Primary Outcome Measure Information:
Title
change of visual analogue scale
Description
a scale from 0 to 10 as the patient will be asked to express his pain on the scale higher scale means a worse outcome
Time Frame
change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement
Secondary Outcome Measure Information:
Title
time for fisrt analgesic request
Description
when VAS is 4 or more longer time means a better outcome
Time Frame
up to 48 hours
Title
total morphine consumption
Description
intraoperative and post operative higher consumption means a worse outcome
Time Frame
up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I or II physical status
undergoing elective major knee surgery
Exclusion Criteria:
refusal of the patients to give informed consent,
preexisting coagulation disorders,
known allergies to aminoamide local anesthetics,
local infection at the site of the block,
morbid obesity,
hepatic and renal diseases
patients with psychological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa saieed saieed mansour, MD
Phone
01225484055
Email
mostafa.said@med.menofia.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, University Hospitals
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada Ali, MD
Phone
01001775783
Email
ghadaali132@yahoo.com
12. IPD Sharing Statement
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Sciatic Nerve Block, Adductor Canal Block, or IPACK Block
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